Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial

Completed

• Conditions: SARS-CoV2 Infection
• Interventions: Other: Fulfilling Questionaires

• Registration Number: NCT04883190
• Lead Sponsor: Hegau-Bodensee-Klinikum Singen

Brief Summary

Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.

Detailed Description

After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).

And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.

The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Study Start: 2021-05-15
• Primary Completion: 2022-06-01
• Status Verified: 2024-02
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

Patient must meet ALL of the following criteria.

1. Participation in the FSC19-KN study
2. Consent to participate in the survey

Exclusion Criteria

1. Failure to give consent to the survey

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1. after SARS-CoV-2 infection	Fulfilling Questionaires	All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group.
2. control group with negative antibody test	Fulfilling Questionaires	All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group.

Primary Outcome Measures

Name	Time	Method
Presence of fatigue	12 month after infection	Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue

Secondary Outcome Measures

Name	Time	Method
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.	12 month after infection	analyzed by PHQ-D (brief)

Trial Locations

Locations (1)

Hegau Bodensee Klinikum Singen; 🇩🇪 Singen, BW, Germany